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510(k) Data Aggregation

    K Number
    K191362
    Device Name
    LifeFlow Blood System
    Manufacturer
    410 Medical, Inc.
    Date Cleared
    2020-05-20

    (364 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    410 Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeFlow® Blood System is an intravenous administration set that is intended for the rapid* delivery of blood, blood components (red blood cells or plasma), and crystalloid and colloid resuscitative fluids from a container to a patient's vascular system. These devices may be used for any adult or pediatric patient, greater than 28 days old and greater than 3kg, with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused, and duration of therapy. The delivery of blood products is intended for patients requiring volume replacement for hemorrhagic shock or life-threatening bleeding. *Capable of rates greater than 100ml/min
    Device Description
    The LifeFlow® Blood System is a single use, disposable, intravenous administration set that is intended to deliver blood, blood components (red blood cells or plasma), and IV fluids from a container to a patient's vascular system rapidly using a hand pump. The set includes the handle, syringe, and tubing. The blood tubing features two IV spikes with roller clamps, blood filter chamber, force reduction tubing, and luer connector.
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